Label: HEALTH SMART MEDICATED BODY- menthol and zinc oxide powder

  • NDC Code(s): 52862-020-22
  • Packager: International Wholesale Inc dba Home Smart Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 11, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol        0.15%

    Zinc Oxide      1.0%

  • PURPOSE

    Purpose

    External Analgesic

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of pains and itch associated with:

    • Minor Cuts
    • Scrapes
    • Sunburn
    • Insect Bites
    • Prickly Heat
    • Rashes
    • Minor Burns
    • Minor Skin Irritation
    • Dries the oozing of poison ivy, oak, and sumac.

  • WARNINGS

    Warnings

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes.

  • ASK DOCTOR

    Consult a doctor and discontinue use if

    • condition worsens
    • symptoms do not get better within 1 week or clear up and occurs again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 2 years and over

    • apply to the affected area not more than 3 or 4 times daily.
    • children under 2 years of age: consult a physician.
    • for best results, dry skin thoroughly before use.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    talc, acacia, eucalyptus oil, methyl salicylate, salicylic acid, thymol, zinc stearate.

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    HEALTH SMART MEDICATED BODY POWDER

    NET WT. 10 OZ. (283g)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    HEALTH SMART MEDICATED BODY 
    menthol and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    ACACIA (UNII: 5C5403N26O)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    THYMOL (UNII: 3J50XA376E)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-020-22283 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/27/2014
    Labeler - International Wholesale Inc dba Home Smart Products (161872676)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-020)
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